Testing Darifenacin against a placebo for amyotrophic lateral sclerosis

Exclusion

• −Patients with a known history of severe allergic or anaphylactic reactions to antimuscarinic medications
• −Subject has a history of, or positive test result at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →, for hepatitis C virus antibody.
• −Subjects with acute or prolonged hepatitis B \& C.
• −Patients with, or at risk for, the following conditions:
• −Untreated or uncontrolled narrow-angle glaucoma;
• −Gastric retention
• −Urinary retention
• −Liver disease
• −If diagnosed with another neurodegenerative disease (e.g. Multiple Sclerosis, Parkinson, Myasthenia Gravis, and Alzheimer's disease).
• −Subjects with severe hepatic impairment or abnormal liver enzymes, as defined as Child-Pugh B and C scores.
• −Any medical condition that might interfere with the patient's participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient according to the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgement.
• −Subjects with any uncontrolled (unresolved) medical condition other than ALS, as determined by the Investigator.
• −Subjects who are currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in another clinical trialInterventional studyA study where participants are given something to see what happens.Read more → and receiving an Investigational Product (IP) (including but not limited to stem cell therapy or gene therapy).
• −Treatment with an investigational drug within 1 month or within a time period equal to 5 half-lives (if known) whichever is longer, of starting study treatment.
• −Patients with prior darifenacin treatment.
• −History of drug and/or alcohol abuse (according to Diagnostic and Statistical Manual of Mental Disorders) prior to the screening as determined by the Investigator.
• −Subjects with an abnormal electrocardiogram (ECG) at screening (any abnormality that the PI believes that entering the study place the participant at risk).
• −Subjects who are receiving strong CYP3A4 inducers such as carbamazepine (anticonvulsant), phenytoin (anticonvulsant), rifampin (antibiotic), and modafinil (wakefulness-promoting agent).
• −Subjects who are receiving potent CYP3A4 inhibitors such as clarithromycin (macrolide antibiotic), ketoconazole and itraconazole (antifungal medications), nefazadone (antidepressant), nelfinavir and ritonavir (protease inhibitors).
• −Subjects who are receiving or received within 30 days prior to the starting of the trial CYP2D6 substrates with a narrow therapeutic window such as include flecainide (Class IC anti-arrhythmic), thioridazine (antipsychotic) and tricyclic antidepressants.
• −Subjects who are receiving or received botulinum injections in the past 6 months.
• −Subjects who are receiving or received within 30 days prior to the starting of the trial antimuscarinic medications for the treatment of overactive bladder such as fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium.
• −Only for patients that consented to the Optional Needle Muscle Biopsy procedures.
• −Subject is taking an anticoagulant (with the exception of aspirin at the investigator's discretion) or is at risk of increased or uncontrolled muscle biopsy-related bleeding.
• −Subjects with bleeding risk factors which include, but are not limited to, anatomical factors at or near the muscle biopsy siteTrial siteA hospital or clinic where a study is actually run.Read more → (e.g., vascular abnormalities, neoplasms, or other abnormalities) or abnormal platelet or coagulation test values at visit 1.
• −If female, subjects who are pregnant, breastfeeding, or intending to conceive during the course of the study.